Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser

Launched by CARL ZEISS MEDITEC AG · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a type of laser eye surgery called PRESBYOND, which is designed to help people aged 45 to 65 who are having trouble seeing things close up due to aging, a condition known as presbyopia. The main goal is to find out how well patients can see at different distances—far away, at arm's length, and up close—after the surgery, and to learn how satisfied they are with their vision afterward.

If you're between 45 and 65 years old and have good distance vision (20/20 or better) but struggle with near vision, you might be eligible to participate. You'll need to stop wearing contact lenses for a short time before your eye exams, and you'll attend a total of seven visits over six months, including before and after the surgery. During these visits, you'll undergo the laser treatment and complete some vision tests and surveys about your experience. It’s important to know that this study does not have a comparison group, meaning all participants will receive the same treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects between 45 and 65 years old
• • 2. Scheduled to undergo bilateral LASIK treatment with PRESBYOND
• • 3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
• • 4. Normal corneal topography in each eye
• • 5. Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
• • 6. Residual stromal thickness ≥250 microns in each eye
• • 7. Availability, willingness, to comply with examination follow up visits
• • 8. Signed informed consent and data protection documents
• • 9. Patients successfully passed the tolerance test
• Exclusion Criteria:
• • 1. Mixed astigmatism in any eye
• • 2. Irregular corneal astigmatism in any eye
• • 3. Clinically significant ocular surface disease in any eye
• • 4. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye
• • 5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
• • 6. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
• • 7. Clinically significant pupil abnormalities in any eye
• • 8. Use of systemic or ocular medications that may affect visual outcomes
• • 9. Systemic pathology that may affect the results of the study
• • 10. Pregnancy or being treated for conditions associated with hormonal fluctuation
• • 11. Participation in another clinical trial in the last 30 days